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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01502709 |
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Date of registration:
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06/12/2011 |
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Primary sponsor: |
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Public title:
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Neurostimulation in Temporomandibular Disorders (TMD) Patients
CVS |
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Scientific title:
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Randomized Blinded Placebo-Controlled Clinical Trial of Caloric Vestibular Neurostimulation in Patients With Chronic TMD |
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Date of first enrolment:
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December 2011 |
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Target sample size:
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20 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT01502709 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Asma Khan, BDS, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina, Chapel Hill |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Aged 18-65 years
- English speaking
- Females with chronic TMD
Exclusion Criteria:
- History of any of the following: Terminal, progressive and /or unstable medical
illness; Previous head or neck surgery for neoplasm; current chemotherapy or
radiation therapy; facial trauma or orofacial surgery within the last 6 weeks;
seizures, history of drug or alcohol abuse; Otologic disorders including chronic
vertigo, chronic tinnitus, otitis external, otitis media, mastoiditis and tympanic
membrane perforation; Stroke, transient ischemia attacks or Arnold- Chiari
malformation; significant cardiac or respiratory disease; epilepsy or neurological
disorders such as dementia, brain injury, and brain tumor
- Subjects who score =31 on the Becks depression inventory (performed at first
appointment)
- History of or current destructive nerve therapies, defibrillator, pacemakers, deep
brain stimulator, or Implantable nerve stimulators
- Utilization of other alternative or complementary therapies during the study period
- Participation in a clinical trial involving the use of a clinical devise in the last
30 days
- Women who are currently pregnant or nursing.
- Patients who are left handed.
- Current orthodontic treatment.
- Use of an opiate in the 48 hour period preceding the baseline study visit
- The use of anti-histamines 6 hours before, during or immediately after the treatment
period
- The use of anti-nausea or anti-vertigo drugs 6 hours before or during the treatment
period
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Chronic Temporomandibular Disorders
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Intervention(s)
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Device: Placebo
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Device: Scion Neurostim, LLC, Caloric Vestibular Neurostimulation Device
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Primary Outcome(s)
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pain intensity as reported on the VAS
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Adverse events
[Time Frame: 4 weeks]
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Change in composite pain index
[Time Frame: Baseline, weeks 1,2,3,4]
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Change in signs and symptoms of TMD based on outcomes of RDC exam
[Time Frame: Baseline, weeks 1,2,3,4]
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Secondary ID(s)
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CVS-TMD-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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